Royalty Report: Drugs, Pharmaceuticals, Therapeutic – Collection: 28650

License Grant

Under the License Agreement, the Licensor will have the responsibility for obtaining regulatory approval and the Licensee will have responsibility for the commercialization of products containing a combination of immediate release omeprazole and 325 mg or less of delayed release aspirin, including PA32540 and PA8140. Under the License Agreement, the Licensee has the exclusive right to commercialize Licensed products in the United States, with the Licensor retaining the right to commercialize Licensed products outside the United States. The Licensee will have responsibility for all sales, marketing and future development for the Licensed products. In addition, following approval of the NDA and completion of certain manufacturing milestones, the Licensee  will have responsibility for manufacturing the Licensed products for commercialization in the United States.

License Property

Products under the agreement include products containing a combination of immediate release omeprazole and 325 mg or less of delayed release aspirin, including PA32540 and PA8140, which are expected to be indicated for use for the secondary prevention of cardiovascular disease in patients at risk for aspirin-associated gastric ulcers.

Stomach ulcers, also known as gastric ulcers, are open sores that develop on the lining of the stomach. Ulcers can also occur in part of the intestine just beyond the stomach. These are known as duodenal ulcers.

License Grant

The company entered into an agreement to assume the remaining commercial rights to Omeclamox-Pak for the United States.  The Company will continue to market and sell Omeclamox-Pak and is now responsible for the supply chain, national accounts and all sales promotion as part of the agreement.  The Company will continue promotion to the gastroenterology community through its field sales force and seek a new co-promotion partner with national primary care capabilities in the U.S.

License Property

Omeclamox-Pak is a branded prescription product that combines omeprazole, amoxicillin and clarithromycin for the treatment of Helicobacter pylori (H. pylori) infection and duodenal ulcer disease.

Field of Use

Helicobacter pylori (H. pylori) is a type of bacteria. These germs can enter your body and live in your digestive tract. After many years, they can cause sores, called ulcers, in the lining of your stomach or the upper part of your small intestine.
A duodenal ulcer is a peptic ulcer that develops in the first part of the small intestine (duodenum).

License Grant

The company transferred to the Licensee, a Swedish corporation, the Investigational New Drug (IND) and New Drug Applications (NDA) for the product.  The Licensee is responsible for the commercialization of VIMOVO.  The Licensee will have rights to commercialize VIMOVO outside of the United States.

License Property

VIMOVO is the brand name for a proprietary fixed-dose combination of enteric-coated naproxen, a pain-relieving NSAID and immediate-release esomeprazole magnesium, a PPI, in a single delayed-release tablet and is a product in our PPI-NSAID (“PN”) platform.  It is for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers

Field of Use

This agreement pertains to the drug industry relating to the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.  Also to decrease the risk of gastric ulcers.

License Grant

Licensee of Curacao exercised its option under the Strategic Alliance Agreement to add the Optional Products Omeprazole DR, 10, 20 and 40 mg to the Agreement as Tier 1 Products. The Omeprazole 40 mg is specifically excluded from this letter agreement.

License Property

Omeprazole Delayed Release Capsules are a generic version of Prilosec(R) marketed by AstraZeneca for the treatment of duodenal/gastric ulcers and GERD (gastro-esophageal reflux disease).

Field of Use

Licensee markets products through three different channels, including Sale of prescription (Rx) products, such as Bupropion Hydrochloride and Omeprazole, exclusively, through marketing partners, pursuant to strategic alliance agreements, called Rx Partners.